Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer

Breast Cancer Clinical Trial

— KSF2  

Official title:

Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03795246
• Other study ID #: KSF2-1707
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: January 2028

Study information

• Verified date: February 2022
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

Description:

The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy. They will have a consultation in oncology consisting of: - a clinical exam, - a collection and follow-up of oncological data - a collection of ongoing cancer treatments and a consultation in gynecology consisting of: - a pelvic ultrasound scan (for AFC: Antral Follicle Count) - a biological test (FSH, LH, E2, AMH) - a collection of gynecological data, contraception and reproductive medicine

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients included in the study CT 01614704
• Informed and written consent
• Affiliated to the National Social Security System

Exclusion Criteria:

• Impossibility to submit at the study procedures due to geographic, social or mental reasons
• Patient deprived of their liberty or under guardianship or tutorship.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Consultation
Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine

Biological:
• Biological Test
Blood test: FSH, LH, E2 and AMH 4 tubes of 7 mL

Procedure:
• Pelvic Ultrasound
Antral Follicles Count

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of fertility in terms of cumulative incidence of long-term pregnancy	for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation	10 years after chemotherapy
Secondary	Assessment of fertility in terms of cumulative incidence of births	separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation	10 years after chemotherapy
Secondary	Assessment of fertility - number of pegnancies spontaneous versus assisted	describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)	10 years after chemotherapy
Secondary	Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately	describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation	10 years after chemotherapy
Secondary	Assessment of the number of patient willing to re-exploit their frozen gametes	for patients who have had Controlled Ovarian Hyperstimulation	10 years after chemotherapy
Secondary	Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate	in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation	10 years after chemotherapy
Secondary	Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count	in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation	10 years after chemotherapy
Secondary	Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse	Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence	After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy